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Fractures of the distal end of the radius are one of the most frequent fractures diagnosed in the emergency room. The initial management, and in many cases definitive, is carried out through manipulation, closed reduction and immobilization in the emergency room. Different methods of anesthesia have been described to reduce pain during the manipulation and reduction procedure, such as: hematoma block, periosteal block, general anesthesia, intravenous regional anesthesia, nitrous oxide, intramuscular sedation, and conscious sedation. Despite the use of different methods of anesthesia, none is fully effective and each of these methods is not free of complications. Adjuvant measures could play an important role in improving the patient's experience during the procedure, however, there is little evidence in this regard.
Music is increasingly being studied and developed as an adjunctive therapy in the management of pain and anxiety in different medical procedures, demonstrating a statistically significant reduction in pain and anxiety. However, in the literature there is no evidence of studies that evaluate the effect of music during the reduction of fractures in traumatology as an adjuvant therapy for the management of pain and anxiety.
In our experience, despite the anesthesia used, reductions of distal radius fractures are usually a painful procedure that involves a certain degree of discomfort for the patient. For this reason, the investigators believe this study is necessary, as it could demonstrate a new adjuvant therapy that reduces pain and anxiety and improves the overall experience of the patient, in addition to being music, a low-cost tool with no risks for patient safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Music | Placebo Comparator | Intervention without music |
|
| Music | Active Comparator | Intervention while listening to music |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Music | Device | No listening to music while intervention is carried out |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VAS scale for pain | It will be completed after the procedure and the punctuation will go from 0 to 10 | Will be completed just after the fracture immobilization |
| Change in Anxiety STAI-6 | Puntuation between 20 and 80, 50 considered high anxiety level | Done just before and after the pfracture immobilization |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac frequency | Measurement of the cardiac frequency assessed before, during and after fracture immobilization | Will be assessed just before, during and after the fracture immobilization |
| Blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrique Cueva, Doctor | Contact | 937 23 10 10 | 21660 | enrique.cueva.sevieri@gmail.com |
| Mireia Viñas, Doctor | Contact | 937 23 10 10 | 21660 | mmvinas@tauli.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Parc Taulà | Recruiting | Sabadell | Barcelona | 08208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34288886 | Background | Chhabra AB, Yildirim B. Adult Distal Radius Fracture Management. J Am Acad Orthop Surg. 2021 Nov 15;29(22):e1105-e1116. doi: 10.5435/JAAOS-D-20-01335. | |
| 28920036 | Background | Tabrizi A, Mirza Tolouei F, Hassani E, Taleb H, Elmi A. Hematoma Block Versus General Anesthesia in Distal Radius Fractures in Patients Over 60 Years in Trauma Emergency. Anesth Pain Med. 2016 Nov 27;7(1):e40619. doi: 10.5812/aapm.40619. eCollection 2017 Feb. |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Music |
| Device |
Listening to music while intervention is carried out |
|
Measurement of the blood pressure will be assessed before, during and after fracture immobilization
| Will be assessed just before, during and after the fracture imobilization |
| Satisfaction after procedure | 1 to 5 scale for satisfaction with the procedure | Just after the immobilization, when patient will be discharged |
| 27760797 | Background | Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19. |
| 32787892 | Background | Sprague S, Scott T, Dodds S, Pogorzelski D, McKay P, Harris AD, Wood A, Thabane L, Bhandari M, Mehta S, Gaski G, Boulton C, Marcano-Fernandez F, Guerra-Farfan E, Hebden J, O'Hara LM, Slobogean GP; PREP-IT Investigators. Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials. Trials. 2020 Aug 12;21(1):712. doi: 10.1186/s13063-020-04611-9. |
| 31413496 | Background | Low S, Papay M, Eingartner C. Pain Perception following Initial Closed Reduction in the Preoperative Care of Unstable, Dorsally Displaced Distal Radius Fractures. J Hand Microsurg. 2019 Aug;11(2):111-116. doi: 10.1055/s-0039-1688681. Epub 2019 May 26. |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |